Objective: To close gaps between research and clinical practice, tools are needed for efficient pragmatic trial recruitment and patient-reported outcome(PROM) collection. The objective was to assess feasibility and process measures for patient-reported outcome collection in a randomized trial comparing electronic health record(EHR) patient portal questionnaires to telephone interview among adults with epilepsy and anxiety or depression symptoms.

Results: Participants were 60% women, 77% White/non-Hispanic, with mean age 42.5 years. Among 15 individuals randomized to EHR portal, 10(67%, CI 41.7-84.8%) met the 6-month retention endpoint, versus 100%(CI 79.6-100%) in the telephone group(p=0.04). EHR outcome collection at 6 months required 11.8 minutes less research staff time per participant than telephone (5.9, CI 3.3-7.7 vs. 17.7, CI 14.1-20.2). Subsequent telephone contact after unsuccessful EHR attempts enabled near complete data collection and still saved staff time.

Discussion: Data from this randomized pilot study of pragmatic outcome collection methods for patients with anxiety or depression symptoms in epilepsy includes baseline participant characteristics, recruitment flow resulting from a novel EHR-based, care-embedded recruitment process, and data on retention along with various process measures at 6-months.

The dataset was collected via a combination of the following: 1. manual extraction of EHR-based data followed by entry into REDCap and then analysis and further processing in SAS 9.4; 2. Data pull of Epic EHR-based data from Clarity database using standard programming techniques, followed by processing in SAS 9.4 and merging with data from REDCap; 3. Collection of data directly from participants via telephone with entry into REDCap and further processing in SAS 9.4; 4. Collection of process measures from study team tracking records followed by entry into REDCap and further processing in SAS 9.4.  One file in the dataset contains aggregate data generated following merging of Clarity data pull-origin dataset with a REDCap dataset and further manual processing.

Recruitment for the randomized trial began at an epilepsy clinic visit, with EHR-embedded validated anxiety and depression instruments, followed by automated EHR-based research screening consent and eligibility assessment. Fully eligible individuals later completed telephone consent, enrollment and randomization. Thirty total participants were randomized 1:1 to EHR portal versus telephone outcome assessment, and patient-reported and process outcomes were collected at 3- and 6-months, with primary outcome 6-month retention in EHR arm(feasibility target: ≥11 participants retained).  Variables in this dataset include recruitment flow diagram data, baseline participant sociodemographic and clinical characteristics, retention (successful PROM collection at 6 months), and process measures. The process measures included research staff time to collect outcomes, research staff time to collect outcomes and enter data, time from initial outcome collection reminder to outcome collection, and number of reminders sent to participants for outcome collection. PROMs were collected via the randomized method only at 3 months. At 6 months, if the criteria for retention was not met by the randomized method (failure to return outcomes by 1 week after 5 post-due date reminders for outcome collection), up to 3 additional attempts were made to collect outcomes by the alternative method, and process measures were also collected during this hybrid outcome collection method approach.